Surgical procedures are often impeded by bleeding and/or leakage of body fluids. These complications cannot always be resolved by conventional surgical techniques. Hemopatch® is a hemostatic patch that also functions as a sealant. Here we document the effectiveness and safety of Hemopatch® for routine procedures of multiple surgical disciplines. To this end, we performed a prospective, multicenter, single-arm, observational registry study. Patients were eligible if they had received Hemopatch® during an open or minimally invasive procedure in one of these specialties: hepatobiliary, cardiovascular, urological, neurological/spinal, general, or lung surgery. Patients were excluded if they had a known hypersensitivity to bovine proteins or brilliant blue, intraoperative pulsatile or severe bleeding and/or infection at the target application site (TAS). The primary endpoint for intraoperative effectiveness was hemostasis assessed as the percentage of patients achieving hemostasis within 2 min and the percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure. The registry enrolled 621 patients at 23 study sites in six European countries. Six hundred twenty patients had completed follow-up information. Hemostasis within 2 min was achieved at 463 (74.5%) of all 621 TASs. Hemostasis without re-bleeding was observed at 620 (99.8%) TASs. Adverse events were reported in 64 patients (10.3%). This Hemopatch® registry shows that Hemopatch® efficiently establishes hemostasis and sealing in a variety of surgical specialties, including minimally invasive procedures. Furthermore, we provide evidence for the safety of Hemopatch® across all the specialties included in the registry. This study is registered at clinicaltrials.gov: NCT03392662.

• MeSH
• hemostatika * škodlivé účinky   MeSH
• hemostáza chirurgická metody   MeSH
• krvácení při operaci MeSH
• lidé MeSH
• obory chirurgické * MeSH
• prospektivní studie MeSH
• registrace MeSH
• skot MeSH
• výsledek terapie MeSH
• zvířata MeSH
• Check Tag
• lidé MeSH
• skot MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• pozorovací studie MeSH

Cieľ práce: Autori hodnotia význam Gleasonovho skóre (GS), lokalizácie nádoru a počtu pozitívnych vzoriek získaných transrektálnou biopsiou. Výsledky sa porovnávajú s histologickým hodnotením preparátu po radikálnej prostatektómii. Materiál a metódy: Z obdobia od 11/2003 do 10/2005 sa hodnotí 130 biopsií prostaty a preparátov po radikálnej prostatektómii, urobených na jednom pracovisku. Výsledky: U 71 (55 %) pacientov sa zistil na základe biopsie prostaty nádor iba v jednom laloku. U 59 (45 %) pacientov sa dokázal tumor v oboch lalokoch. Spracovaním preparátov po radikálnej prostatektómii sa karcinóm vyskytol v oboch lalokoch u 55 (77 %) zo 71 pacientov s karcinómom diagnostikovaným v jednom laloku pri biopsii. U 12 (17 %) zo 71 pacientov sa lokalizácia zhodovala s biopsiou. U dvoch zo 71 pacientov sa nepodarilo dokázať karcinóm v chirurgickom preparáte (pT0). V dvoch prípadoch sa karcinóm diagnostikoval v preparáte v opačnom laloku. U 114 (87,7 %) zo 130 pacientov karcinóm prostaty v chirurgickom preparáte postihoval oba laloky prostaty. Pri biopsii sa diagnostikoval karcinóm v oboch lalokoch iba pri 45 % pacientov. Zhoda v GS sa našla u 39 (30 %) zo 128 pacientov. Nadhodnotenie GS pri biopsii sa zistilo u 10 (8 %). K podhodnoteniu GS došlo v 62 % prípadov. Pravdepodobnosť zhody GS bola 61 % pri GS = 7, 15 % pri GS < 7 a 22 % pri GS > 7. Pravdepodobnosť podhodnotenia GS pri biopsii prostaty bola 34 % pri GS = 7, 81 % pri GS < 7 a 22 % pri GS > 7. Pravdepodobnosť nadhodnotenia GS pri biopsii prostaty bola 5 % pri GS = 7, 4 % pri GS < 7 a 56 % pri GS > 7. Zo 130 pacientov sedem dostalo neoadjuvantnú hormonálnu liečbu. U týchto pacientov sa nezistilo zníženie GS. Pri GS < 7 malo 70 (92,1 %) zo 76 pacientov lokalizované ochorenie a 6 (7,9 %) extrakapsulárne šírenie, postihnutie lymfatických obturatórnych uzlín sa zistilo len v jednom prípade. Pri GS ≥ 7 malo 35 (67,3 %) z 52 pacientov lokalizovaný tumor v chirurgickom preparáte, 17 (32,7 %) extrakapsulárne šírenie a štyria (7,7 %) postihnutie lymfatických obturatórnych uzlín. Ak bol počet pozitívnych vzoriek ≤ 10 %, bolo ochorenie lokalizované u 35 (97,2 %) z 36 pacientov, extrakapsulárne šírenie u jedného pacienta a postihnutie lymfatických uzlín sa nedokázalo. Pri > 50 % pozitívnych bioptických vzoriek sa zistil lokalizovaný tumor u 9 (56,2 %) zo 16 pacientov. Extrakapsulárne šírenie postihlo 7 (43,8 %) zo 16 pacientov a traja (18,8 %) z nich mali aj pozitívne lymfatické uzliny. Záver: Dnes nejestvuje spoľahlivý klinický parameter, podľa ktorého by bolo možné v čase diagnózy karcinómu prostaty presne určiť jeho biologické správanie. Lokalizácia nádoru na základe biopsie prostaty sa často nezhoduje so skutočným nálezom v chirurgickom preparáte. Hodnota GS sa vo väčšine prípadov mení. Počet pozitívnych vzoriek pri biopsii koreluje s lokálnym rozsahom ochorenia. V čase diagnózy karcinómu prostaty sa odporúča vziať do úvahy aj ďalšie dostupné klinické parametre (hladina sérového PSA a digitálny rektálny nález). Vyšší počet odobraných vzoriek pri biopsii prostaty neprispieva k spresneniu odhadu GS v definitívnom preparáte.

Objective: Authors evaluate the role of Gleason´s score (GS), localization of tumor and the amount of positive samples obtained by transrectal biopsy. Results are compared with histological findings after radical prostatectomy. Material and methods: During 11/2003 - 10/2005 130 prostate biopsies and radical prostatectomies were done. Biopsy samples and surgical specimens were evaluated. At the same department. Results: Tumor in one lobe was detected on the basis of prostate biopsy in 71 (55 %) patients. In 59 (45 %) patients tumor was detected in both lobes. Samples evaluated after radical prostatectomy revealed carcinoma in both lobes in 55 (77 %) out of 71 patients with carcinoma in one lobe diagnosed by biopsy. Localization corresponded with biopsy in 12 (17 %) out of 71 patients. Carcinoma was not found in surgical sample (pT0) in two out of 71 patients. In two cases carcinoma was diagnosed in the sample in the other lobe. In 114 (87.7 %) out of 130 patients the prostate carcinoma in surgical sample was found in both lobes of the prostate. Carcinoma in both lobes was diagnosed in the biopsy samples only in 45 % of patients. Correspondence in GS was found in 39 (30 %) out of 128 patients. Overestimated GS in biopsy was found in 10 (8 %) patients. Underestimated GS was found in 62 % of cases. Probability of GS correspondence was 61 % in GS = 7, 15 % in GS < 7 and 22 % in GS > 7. Probability of GS underestimation in prostate biopsy was 34 % in GS = 7, 81 % in GS < 7 and 22 % in GS > 7. Probability of GS overestimation in prostate biopsy was 5 % in GS = 7, 4 % in GS < 7 and 56 % in GS > 7. Seven patients out of 130 received neoadjuvant hormonal therapy. Decrease of GS was not revealed in these patients. In GS < 7 70 patients (92.1 %) out of 76 patients had localized disease and 6 (7.9 %) had extracapsular spreading, metastatic spreading of lymphatic obturator nodes was revealed in one case. In GS ≥ 7 35 (67.3 %) out of 52 patients had localized tumor in surgical sample, 17 (32.7 %) extracapsular spreading and four (7.7 %) metastatic spreading of lymphatic obturator nodes. If the number of positive bioptic samples was ≤ 10 %, disease was localized in 35 (97.2 %) out of 36 patients, extracapsular spreading in one patient and metastatic spreading of lymphatic nodes was not confirmed. If > 50 % bioptic samples were positive, tumor was localized in 9 (56.2 %) out of 16 patients. Extracapsular spreading was found in 7 (43.8 %) out of 16 patients and three of them (18.8 %) had also positive lymphatic nodes. Conclusion: Currently there does not exist any reliable clinical parameter used to determine biological behaviour of prostate carcinoma. Tumor localization on the basis of prostate biopsy often does not correspond with a real finding in surgical sample. GS score varies in most cases. The number of positive samples in biopsy correlates with local extent of the disease. Available clinical parameters (serum PSA level and digital rectal finding) should be considered in the time of diagnosis of prostate carcinoma. A higher number of samples in prostate biopsy does not contribute to accurate assessment of GS in definite sample.

• MeSH
• adrenalektomie metody   MeSH
• laparoskopie metody   MeSH
• retroperitoneální prostor chirurgie   MeSH

• Konspekt
• Patologie. Klinická medicína
• NLK Obory
• urologie
• chirurgie
• NLK Publikační typ
• DVD

• MeSH
• lékařské ilustrace dějiny   MeSH
• urologie dějiny   MeSH

• Konspekt
• Patologie. Klinická medicína
• NLK Obory
• urologie
• dějiny lékařství
• humanitní vědy a umění
• NLK Publikační typ
• kolektivní monografie